Two degree of freedom system and method for spinal applications

ABSTRACT

A method and system to align a pin or drill a tunnel along a single line in space with a two degree of freedom (2-DOF) surgical device in a patient is provided. A plane is defined relative to a desired location for an implant or tunnel on a bone, where the implant or tunnel has an axis. An end-effector of the 2-DOF surgical device is aligned coincident with the plane, and the 2-DOF surgical device is moved side-to until a first indicator signals when the end-effector aligns with an entry point for the desired location for the implant or tunnel on the bone. A tip of the end-effector is anchored into the bone at the entry point; and the 2-DOF surgical device is rotated about the anchored tip until a second indicator signals when the end-effector aligns with the axis of the implant or tunnel at the desired location.

RELATED APPLICATIONS

This application a continuation-in-part of PCT Application NumberPCT/US2018/022378 filed 14 Mar. 2018 that in turn claims prioritybenefit of U.S. Provisional Application Ser. No. 62/474,313 filed 21Mar. 2017, the contents of which are hereby incorporated by reference.

FIELD OF THE INVENTION

The present invention generally relates to computer assisted surgery,and more specifically to systems and methods for aligning a two degreeof freedom device along a line representative of an optimal and plannedtrajectory and for aligning and inserting a pedicle screw through thepedicle in a desired position and orientation based on a preoperativeplanned optimal trajectory.

BACKGROUND

A two degree of freedom (2-DOF) Surgical System is well suited foraligning pins on a plane or cutting along a plane. However, the 2-DOFsurgical system lacks degrees of freedom to align a pin (or drill atunnel) along a single line in space. Having the ability to align the2-DOF surgical system on a line is particularly advantageous fordrilling bone tunnels (e.g., ACL reconstruction) or inserting screwsinto a bone (e.g., pedicle screws for spine). In currently pending PCTapplication PCT/US2018/022378 filed 14 Mar. 2018 that is included hereinin its entirety, the use of a 2-DOF system for inserting pedicle screwsinto a pedicle (essentially aligning the 2-DOF on a line). The remainingdegrees of freedom were accounted for in that application using visualfeedback from a monitor and blinking light emitting diodes (LEDs) on thedevice.

The vertebral column, also known as the backbone or spinal column, ispart of the axial skeleton. The vertebral column is made up of asegmented series of bones called vertebrae that are separated byintervertebral discs. The vertebral column houses the spinal canal, acavity that encloses and protects the spinal cord. In the humanvertebral column, there are normally thirty-three vertebrae; the uppertwenty-four are articulating and separated from each other byintervertebral discs, and the lower nine are fused in adults, five inthe sacrum and four in the coccyx or tailbone. The articulatingvertebrae are named according to their region of the spine. There areseven cervical vertebrae, twelve thoracic vertebrae and five lumbarvertebrae. The pedicle is a narrow piece of bone in the form of a densestem-like structure that projects from the posterior of a vertebra.There are two pedicles per vertebra. A series of pedicles traverse thespinal column and join the transverse process with the vertebral body.

FIGS. 1A and 1B illustrate a segment and a cross sectional view,respectively of a spinal column 10. As shown the spinal column 10 has aseries of vertebrae 12 separated from each by intervertebral discs 14.The pedicles 16 extend from the vertebrae 12 and join the transverseprocess 18 to the vertebrae 12. The spinous process 20 extends from thelamina 22, which are connected to the opposing sides of the transversprocess 18.

A pedicle screw is a particular type of bone screw designed forimplantation into a vertebral pedicle. Pedicle screws are used tocorrect deformity, and/or treat trauma inflicted to a patient spinalcolumn. Pedicle screws may be used in instrumentation procedures toaffix rods and plates to the spine. The screws may also be used toimmobilize part of the spine to assist in decompression of neuralelements (spinal cord, exiting nerve roots, cauda equine contained nervetracks) and fusion by holding bony structures together. FIG. 2 is anX-ray image of pedicle screws 24 inserted in a spinal column 10 ofpatient.

Currently, there are several navigation systems available that providevisual feedback to aid in the alignment of pedicle screws through thepedicle. However, trying to align the pedicle in 5-DOF through thisnarrow piece of bone is often difficult and time consuming when onlyrelying on visual feedback. The procedure becomes even more difficult inthe upper thoracic and cervical regions of the spine as the vertebralpedicles progressively narrow.

The position and orientation (POSE) of the inserted pedicle screws intoa vertebra is highly critical to a safe and successful outcome.Generally, surgeons plan and create an implantation plan so the finalplacement of the implanted screws provides the necessary support orimmobilization to the section of the patient spinal column. Even smallimplant alignment deviations outside of clinically acceptable rangescorrelates to less than optimal outcomes and increased rates of followup surgery.

While improved systems and methods for aligning and inserting a pediclescrew through the pedicle in a desired position and orientation based ona preoperative planned optimal trajectory have been made, therecontinues to be a need for system enhancements and an improved method ofusing a 2-DOF system to align a pin (or drill a tunnel) along a singleline in space.

SUMMARY

A method is provided herein to align a 2-DOF hand-held surgical devicealong an axis. The method includes defining a plane relative to adesired location for an implant or tunnel on a bone, where the implantor tunnel has an axis. An end-effector of the 2-DOF surgical device isaligned coincident with the plane, and the 2-DOF surgical device ismoved side-to-side while the end-effector maintains coincidence with theplane until a first indicator signals when the end-effector aligns withan entry point for the desired location for the implant or tunnel on thebone. Subsequently, a tip of the end-effector is anchored into the boneat the entry point; and the 2-DOF surgical device is rotated about theanchored tip while the end-effector remains coincident with the planeuntil a second indicator signals when the end-effector aligns with theaxis of the implant or tunnel at the desired location. The end-effectoris then inserted into the bone.

A system for implementing the method to align a 2-DOF hand-held surgicaldevice along an axis includes a computing system, an articulating 2-DOFsurgical device, and a tracking system.

BRIEF DESCRIPTION OF THE DRAWINGS

The present invention is further detailed with respect to the followingdrawings. These figures are not intended to limit the scope of thepresent invention but rather illustrate certain attributes thereofwherein;

FIGS. 1A and 1B illustrate a segment and a cross sectional view,respectively of a spinal column;

FIG. 2 in a prior art X-ray image of pedicle screws inserted in apatient's spinal column

FIGS. 3A and 3B depict a surgical system to perform a procedure forimplanting pedicle screws in a patient spinal column and with respect toa knee surgical procedure, in accordance with embodiments of theinvention;

FIGS. 4A and 4B depict a surgical device used in the surgical system;

FIG. 5 illustrates the implantation of pedicle screws in a patientspinal column in accordance with embodiments of the invention;

FIGS. 6A and 6B depict a cross-section of an articulatingpin/screw-driver device, where FIG. 6A depicts the device having apin/screw in a retracted state, and FIG. 6B depicts the device having apin/screw in an extended state in accordance with embodiments of theinvention;

FIG. 6C is an exploded view that illustrates the components of a workingportion of the pin/screw-driver device in accordance with embodiments ofthe invention;

FIGS. 7A and 7B depict and illustrate a bone stability member attachedto the pin-driver device and the use thereof in accordance withembodiments of the invention;

FIGS. 8A and 8B depict a partial enclosure enclosing the working portionin accordance with embodiments of the invention;

FIGS. 9A and 9B depict a full enclosure enclosing the working portion inaccordance with embodiments of the invention

FIG. 10 depicts a 3-D tibial bone model with a planned position of abone tunnel having an axis, and a virtual plane defined relative to thebone tunnel in accordance with embodiments of the invention;

FIG. 11 depicts an end-effector of the two degree of freedom (2-DOF)surgical device aligned coincident with the defined plane, where the2-DOF surgical device is moved side-to-side while the end-effectorremains coincident with the defined plane by the actuation of theworking portion in accordance with embodiments of the invention;

FIG. 12 depicts a tip of the end-effector anchored in the tibia at anentry point of the defined location for the implant or tunnel, where thetip is anchored after an indicator signals when the end-effector isaligned with the entry point in accordance with embodiments of theinvention; and

FIG. 13 depicts the 2-DOF surgical device being rotated about theanchored tip until the end-effector aligns with the defined location ofthe axis of the implant or tunnel, and a second indicator then signalsto the user when the end-effector is aligned with the axis in accordancewith embodiments of the invention.

DETAILED DESCRIPTION OF THE INVENTION

The present invention has utility as a method and system to aid asurgeon in efficiently and precisely positioning a pedicle screw throughthe pedicle of a patient spinal column, and an improved method of usinga 2-DOF system to align an end-effector of a 2-DOF surgical device alonga single line in space.

Embodiments of the inventive method and system in some embodiments,utilize a two degree of freedom (2-DOF) device to aid a surgeon inaligning and inserting a pedicle screw through a targeted pedicle in adesired position and orientation while aligning with a preoperativeplanned optimal trajectory. Embodiments of the inventive method andsystem for pedicle screw placement may use visual feedback or othermechanisms to provide alignment in the remaining relevantdegrees-of-freedom. Use of a handheld actuator in specific embodimentshelps to avoid the possibility of inaccuracy in critical directions dueto unintended mechanical deflection of a drill guide when a drill isused through the handheld actuator, such as when a robot is used to holdthe drill guide.

The method and system are especially advantageous for spinal fusion, andto correct deformity, and/or treat trauma to the spinal column, however,it should be appreciated that other medical applications may exploit thesubject matter disclosed herein such as high tibial osteotomies, spinalreconstruction surgery, and other procedures requiring the preciseplacement for screw implantation.

The following description of various embodiments of the invention is notintended to limit the invention to these specific embodiments, butrather to enable any person skilled in the art to make and use thisinvention through exemplary aspects thereof.

In embodiments of the inventive method, images of the patient spinalcolumn are acquired. These images are readily collected pre-operativelyor intra-operatively with a computer tomography scanner, magneticresonance imaging scanner, fluoroscopy, ultrasound, or otherintracorporal interrogation scanning technique. Two-dimensionalorthogonal planar images or a generated 3-D model of the spinal columnis then generated and used to define a pedicle plane on a pedicle of thespinal column for each of the pedicle screws to be implanted. Atrajectory for each of the pedicle screw to be implanted along thepedicle plane is then determined. In a specific inventive embodiment,the pedicle plane is defined through the center of the pedicle in themedial-lateral direction and in internal-external rotation. This ensuresthat the 2-DOF device accounts for the narrowest region of the pedicle(medial-lateral distance). A monitor, or an on-board indicator on anembodiment of a 2-DOF surgical tool, can provide simultaneous feedbackto allow the user, in real time, to align the pedicle screw in asuperior-inferior translation, an anterior-posterior translation(depth), and a flexion-extension angle (angle of rotation in thesagittal plane). It should be noted that intra-operative registration ofthe patient anatomy relative to any pre-operative images and a referencemarker (e.g., radiopaque marker, fiducial marker, fiducial marker array,mechanically tracked probe, or a combination thereof) on the patientanatomy is performed by traditional means, illustratively including twodimensional/three dimensional (2D/3D) fluoro, structured light, orsurface point registration. The 2-DOF device may then locate the pedicleplane correctly relative to the anatomy, and also can adjust the deviceposition in real-time to accommodate minor patient motion, such as frombreathing or cardiac output.

In terms of planning, a user may locate three medial-lateral (M-L)center points on the pedicle to define the pedicle plane. The user maythen plan the remaining DOFs accordingly, or use real-time visualprogressive feedback like traditional navigation systems for theremaining DOFs.

Embodiments of the 2-DOF device used in inventive embodiments may beconfigured to both drill a pilot hole for a pedicle screw, andsubsequently drive the pedicle screw into the pedicle. An on-boardindicator on the 2-DOF device, illustratively including a light emittingdiode (LED), may provide the user with direct visual feedback when thedevice is aligned in an optimal trajectory and depth perception for thesequential screw advancement and positioning is achieved. Other on-boardmechanisms may illustratively include blinking arrows or the like, canhelp the user align the remaining degrees of freedom in real time.

One or more LED indicators, either on an embodiment of the 2-DOF deviceor in the user's line of sight, can provide further feedback duringpedicle screw advancement to aid in aligning and/or verifying thescrew's optimal position. For example, in a specific embodiment a firstgreen light is used to indicate that the entrance point and trajectoryof the pedicle screw is correct; a second green light may indicate thatmid portion of the pedicle is within a safety zone and the trajectory isconfirmed to be correct; a third green light indicates that an end pointinto vertebral body has been reached and the trajectory of the placementof the pedicle screw is confirmed. When all three LED lights and LEDarrows are lit placement of the pedicle screw is completed successfully.In a specific embodiment, left (L) and right (R) three dimensionalarrows may be used as trajectory guides, potentially utilizingadditional tracking mechanisms illustratively including inertialmeasuring units (IMUs), accelerometers, and gyroscopes.

Embodiments of the present invention may be implemented with a surgicalsystem. Examples of surgical systems used in embodiments of theinvention illustratively include a 1-6 degree of freedom hand-heldsurgical system, a serial-chain manipulator system, a parallel roboticsystem, or a master-slave robotic system, as described in U.S. Pat. Nos.5,086,401, 7,206,626, 8,876,830 and 8,961,536, U.S. Patent PublicationNo. 2013/0060278. In a specific embodiment, the surgical system is aserial-chain manipulator system as described in U.S. Pat. No. 6,033,415assigned to the assignee of the present application and incorporated byreference herein in its entirety. The manipulator system may provideautonomous, semi-autonomous, or haptic control and any combinationsthereof. In a specific embodiment, a tool attached to the manipulatorsystem may be manually maneuvered by a user while the system provides atleast one of power, active or haptic control to the tool.

With reference to the figures, FIGS. 3A and 3B illustrate a2-degree-of-freedom (2-DOF) surgical system 100. The 2-DOF surgicalsystem 100 is generally described in U.S. Patent Publication No.2015/051713, assigned to the assignee of the present application andincorporated by reference herein in its entirety. The 2-DOF surgicalsystem 100 includes a computing system 102, an articulating surgicaldevice 104, and a tracking system 106. The surgical system 100 is ableto guide and assist a user in accurately placing pedicle screwscoincident with a virtual pedicle plane that is defined relative to atargeted pedicle bone on a patient's spinal column as shown in FIG. 3A,and in a tibia or fibula in FIG. 3B. It is appreciated that othersurgical procedures may be conducted with the surgical system 100. Thevirtual plane is defined in a surgical plan such that a pedicle screw isinserted in a planned position and orientation.

Articulating Surgical Device

FIGS. 4A and 4B illustrate the articulating surgical device 104 of the2-DOF surgical system 100 in more detail, where FIG. 4A illustrates thesurgical device 104 in a first working POSE and FIG. 4B illustrates thesurgical device 104 in a second working POSE. The surgical device 104includes a hand-held portion 202 and a working portion 204. Thehand-held portion 202 includes an outer casing 203 of ergonomic designto be held, wielded, and manipulated by a user. The working portion 204includes an end-effector/tool 206 having an axis 207. The tool 206 isreadily attached to and driven by a motor 205. The hand-held portion 202and working portion 204 are connected by a front linear rail 208 a and aback linear rail 208 b that are actuated by components in the hand-heldportion 202 to control the pitch and translation of the working portion204 relative to the hand-held portion 202. A tracking array 212, havingthree or more fiducial markers, is rigidly attached to the workingportion 142 to permit a tracking system 106 to track the POSE of theworking portion 204. The three or more fiducial markers mayalternatively be integrated directly onto the working portion 204. Thefiducial markers may be active markers such as light emitting diodes(LEDs), or passive markers such as retroreflective spheres. The device104 may further include one or more user input mechanisms such as atrigger 214 or a button.

Within the outer casing of the hand-held portion 202 are a frontactuator 210 a that powers a front ball screw 216 a and a back actuator210 b that powers a back ball screw 216 b. The actuators (210 a, 210 b)may be servo-motors that bi-directionally rotate the ball screws (216 a,216 b). A first end of the linear rails (208 a, 208 b) are attached tothe working portion 204 via hinges (220 a, 220 b), where the hinges (220a, 220 b) allow the working portion 204 to pivot relative to the linearrails (208 a, 208 b). Ball nuts (218 a, 218 b) are attached at a secondend of the linear rails (208 a, 208 b). The ball nuts (218 a, 218 b) arein mechanical communication with the ball screws (216 a, 216 b). Theactuators (210 a, 210 b) power the ball screws (216 a, 216 b) whichcause the ball nuts (218 a, 218 b) to translate along the axis of theball screws (216 a, 216 b). Accordingly, the translation ‘d’ and pitch‘α’ of the working portion 204 may be adjusted depending on the positionof each ball nut (218 a, 218 b) on their corresponding ball screw (216a, 216 b). A linear guide 222 may further constrain and guide the motionof the linear rails (208 a, 208 b) in the translational direction ‘d’.

An input/output port in some inventive embodiments of the articulatingsurgical device 104 provides power and/or control signals to the device104; or the device may receive power from batteries and control signalsvia a wireless connection alleviating the need for electrical wiring tobe connected to the device 104. The actuators 210 and motor 205 of thearticulating surgical device 104 may be controlled using a variety ofmethods. In one method, control signals may be provided via anelectrical connection to an input/output port. In another method,control signals are communicated to the device 104 via a wirelessconnection alleviating the need for electrical wiring. The wirelessconnection may be made via optical communication. In a third method, thehand-held portion 202 may house a device computer (or microcontroller)to provide on-board control to the surgical device 104. The on-boarddevice computer may receive external data (e.g., tracking data,informational data, workflow data, etc.) via optical communication.Likewise, the on-board device computer may send internal data (e.g.,operational data, actuator/ball-screw position data, battery life, etc.)via optical communication. In a particular embodiment, the device mayreceive wireless control signals via visible light communication asdescribed in PCT publication WO 2016/081931 and incorporated byreference herein in its entirety.

The articulating surgical device 104 may further include one or moreindicators 224 visible to the user. The one or more indicators 224 maybe a light emitting diode (LED) or other visual indicator to providesignals to the user, such as the signals to notify the user when theposition of the end-effector 206 is aligned with an entry point or axisof the desired location of the implant or tunnel. In specificembodiments, a control system controlling the hand-held surgical device104 contains software that when executed by one or more processorscauses the processor(s) to signal to the user when the end-effector 206is aligned with an entry-point or axis of a desired location of animplant or tunnel by way of the one or more indicators 224. The one ormore indicators 224 may further provide information about the surgicaldevice (e.g., battery life, operating conditions).

Computing System and Tracking System

FIGS. 3A and 3B also detail the computing system 102 that generallyincludes hardware and software for executing a surgical procedure. Inparticular inventive embodiments, the computing system 102 providesactuation commands to the actuators (210 a, 210 b) to control theposition and orientation (POSE) of the end effector/tool 206. Thecomputing system 102 is configured to maintain the end-effector 206coincident with a defined plane independent of the POSE of the hand-heldportion 202. The computing system 102 accurately maintains theend-effector/tool 206 coincident with the plane based on: a) the trackedPOSE of the plane defined or registered to the bone; and b) the trackedPOSE of the working portion 204. The computing system 102 can thusmaintain the tool axis 207 with a virtual plane defined in a surgicalplan independent of the POSE of the hand-held portion 202.

The computing system 102 in some inventive embodiments may include: adevice computer (or microcontroller) 108 including a processor; aplanning computer (or microcontroller) 110 including a processor; atracking computer (or microcontroller) 111 including a processor, andperipheral devices. Processors operate in the computing system 102 toperform computations associated with the inventive system and method. Itis appreciated that processor functions are shared between computers, aremote server, a cloud computing facility, or combinations thereof.

The data gathered by and/or the operations performed by the trackingcomputer 111 and the device computer 108 may work together to controlthe hand-held surgical device 104 and as such, the data gathered byand/or the operations performed by the tracking computer 111 and devicecomputer 108 to control the surgical device 104 may be referred toherein as a “control system”. However, it should be appreciated that thedevice computer 108, the planning computer 110, and the trackingcomputer 111 may be separate entities as shown, or it is contemplatedthat operations may be executed on one or two computers depending on theconfiguration of the surgical system 100. For example, the trackingcomputer 111 may have operational data to control the surgical device104 without the need for a device computer 108. Or, the device computer108 may include operational data to plan to the surgical procedurewithout the need for the planning computer 110. Further, any combinationof the device computer 108, planning computer 110, and/or trackingcomputer 111 may be connected via a wired or wireless connection.

In particular inventive embodiments, the device computer 108 may includeone or more processors, controllers, software, data, utilities, and anyadditional data storage medium such as RAM, ROM or other non-volatile orvolatile memory to perform functions related to the operation of thesurgical device 104. For example, the device computer 108 may includesoftware, data, and utilities to control the surgical device 104 such asthe POSE of the working portion 204, receive and process tracking data,control the speed of the motor 205, execute registration algorithms,execute calibration routines, provide workflow instructions to the userthroughout a surgical procedure, as well as any other suitable software,data or utilities required to successfully perform the procedure inaccordance with embodiments of the invention.

The device computer 108, the planning computer 110, and the trackingcomputer 111 may be separate entities as shown, or it is contemplatedthat their operations may be executed on just one or two computersdepending on the configuration of the surgical system 100. For example,the tracking computer 111 may have operational data to control thedevice 104 without the need for a device computer 108. Or, the devicecomputer 108 may include operational data to plan to the surgicalprocedure with the need for the planning computer 110. In a specificinventive embodiment, the device computer 108 may be located separatefrom the surgical device 104 as shown in FIGS. 3A and 3B, or the devicecomputer 108 may be housed in the hand-held portion 202 of the surgicaldevice 104 to provide on-board control based on information and/ortracking data received from the tracking computer 111.

Peripheral devices allow a user to interface with the surgical system100 and may include: one or more user interfaces, such as a display ormonitor 112 that may be used to display a graphical user interface(GUI); and various user input mechanisms, illustratively including akeyboard 114, mouse 122, pendent 124, joystick 126, foot pedal 128, orthe monitor 112 may have touchscreen capabilities. In addition, thearticulating surgical device 104 may have one or more input mechanismsillustratively including buttons and switches, etc.

The planning computer 110 is preferably dedicated to planning theprocedure either pre-operatively or intra-operatively. For example, theplanning computer 110 may contain hardware (e.g., processors,controllers, and memory), software, data, and utilities capable ofreceiving and reading medical imaging data, segmenting imaging data,constructing and manipulating three-dimensional (3D) virtual models,storing and providing computer-aided design (CAD) files such as bone pinCAD files, planning the POSE of bone tunnels and/or 3-D virtual implantsrelative to the bone, pedicle screw CAD files, planning the POSE ofimplants and/or pedicle screws relative to the bone, providing analysisof region of interest (ROI) pedicle bone density and utilization of ROIinformation to define interface and maximize screw pitch/bone structuralelements integration, generating the surgical plan data for use with thesystem 100, and providing other various functions to aid a user inplanning the surgical procedure. The planning computer also containssoftware dedicated to defining virtual planes with regards toembodiments of the invention as further described below. The finalsurgical plan data may include an image data set of the bone, boneregistration data, subject identification information, the POSE of oneor more pedicle screws relative to the bone, the POSE of one or morevirtual planes defined relative to the bone, and any tissue modificationinstructions. The device computer 108 and the planning computer 110 maybe directly connected in the operating room, or may exist as separateentities. The final surgical plan is readily transferred to the devicecomputer 108 and/or tracking computer 111 through a wired or wirelessconnection in the operating room (OR); or transferred via anon-transient data storage medium (e.g., a compact disc (CD), a portableuniversal serial bus (USB drive)) if the planning computer 110 islocated outside the OR. As described above, the computing system 102 mayact as a single entity, with multiple processors, capable of performingthe functions of the device computer 108, the tracking computer 111, andthe planning computer 110, or any combination thereof. Wirelessconnections for transfer of information and control may include the useof optical signals or radio waves.

The computing system 102 may accurately maintain the tool axis 207 in3-D space based on POSE data from the tracking system 106 as shown inFIG. 3. The tracking system 106 generally includes a detection device todetermine the POSE of an object relative to the position of thedetection device. In a particular inventive embodiment, the trackingsystem 106 is an optical tracking system as described in U.S. Pat. No.6,061,644, having two or more optical receivers 116 to detect theposition of fiducial markers arranged on rigid bodies. Illustrativeexamples of the fiducial markers include: an active transmitter, such asan LED or electromagnetic radiation emitter; a passive reflector, suchas a plastic sphere with a retroreflective film; or a distinct patternor sequence of shapes, lines or other characters. A set of fiducialmarkers arranged on a rigid body is referred to herein as a fiducialmarker array (120 a, 120 b, 120 c, 212), where each fiducial markerarray (120 a, 120 b, 120 c, 212) has a unique geometry/arrangement offiducial markers, or a unique transmitting wavelength/frequency if themarkers are active LEDS, such that the tracking system 106 candistinguish between each of the tracked objects. In a specificembodiment, the fiducial marker arrays (120 a, 120 b, 120 c, 212)include three or more active emitters or passive reflectors uniquelyarranged in a known geometry on each rigid body. In another embodiment,the fiducial marker array attached to the patient (120 a, 120 b) mayinclude fiducial markers and radiopaque markers uniquely arranged in aknown configuration on a rigid body so as to permit image registrationwith fluoro or CT and subsequently track the bone with an opticaltracking system.

The tracking system 106 may be built into a surgical light 118, locatedon a boom, stand, or built into the walls or ceilings of the operatingroom. The tracking system computer 111 includes tracking hardware,software, data, and utilities to determine the POSE of objects (e.g.,bones such as the spinal column 10, the femur F and tibia T, thesurgical device 104) in a local or global coordinate frame. The outputfrom the tracking system 106 (i.e., the POSE of the objects in 3-Dspace) is referred to herein as tracking data, where this POSE data isreadily communicated to the device computer 108 through a wired orwireless connection. Alternatively, the device computer 108 maydetermine the POSE data using the position of the fiducial markersdetected directly from the optical receivers 116.

The tracking or POSE data is determined using the position of thefiducial markers detected from the optical receiver/detectors 116 andoperations/processes such as image processing, image filtering,triangulation algorithms, geometric relationship processing,registration algorithms, calibration algorithms, and coordinatetransformation processing.

POSE data from the tracking system 106 is used by the computing system102 to perform various functions. For example, the POSE of a digitizerprobe 130 with an attached probe fiducial marker array 120 c may becalibrated such that tip of the probe is continuously known as describedin U.S. Pat. No. 7,043,961. The POSE of the tip or axis of the tool 206may be known with respect to the device fiducial marker array 212 usinga calibration method as described in PCT Publication WO 2016/141378.Registration algorithms are readily executed using the POSE data todetermine the POSE and/or coordinate transforms between a bone, asurgical plan, and a surgical system. For example, in registrationmethods as described in U.S. Pat. Nos. 6,033,415 and 8,287,522, pointson a patient's bone may be collected using a tracked digitizer probe totransform the coordinates of a surgical plan, coordinates of the bone,and the coordinates of a surgical device. The bone may also beregistered using image registration as described in U.S. Pat. No.5,951,475. The coordinate transformations may be continuously updatedusing the POSE data from a tracking system tracking the POSE of the bonepost-registration and the surgical device.

It should be appreciated that in certain inventive embodiments, othertracking systems are incorporated with the surgical system 100 such asan electromagnetic field tracking system, ultrasound tracking systems,accelerometers and gyroscopes, or a mechanical tracking system. Thereplacement of a non-mechanical tracking system with other trackingsystems should be apparent to one skilled in the art. In specificembodiments, the use of a mechanical tracking system may be advantageousdepending on the type of surgical system used such as the one describedin U.S. Pat. No. 6,322,567 assigned to the assignee of the presentapplication and incorporated by reference in its entirety.

In the surgical system 100, an optical tracking system 106 with opticalreceivers 116 is used to collect POSE data of the spinal column.Tracking arrays 120 a and 120 b are attached to the spinal column 10where subsequently one or more target vertebral bodies are registered toa surgical plan. In a specific embodiment, the tracking arrays 120 a and120 b are screwed into the spinous process 20. The POSE of the spinalcolumn is tracked in real-time by the tracking system 106 so thecoordinate transformation between the surgical plan and the surgicaldevice are updated as the bones and surgical device move in theoperating space. Therefore, a relationship between the POSE of the tool206 and the POSE of any coordinates defined in the surgical plan may bedetermined by the computing system 102. In turn, the computing system102 can supply actuation commands to the actuators (210 a, 210 b) inreal-time to accurately maintain the tool axis 207 to the definedcoordinates.

Additionally, user input mechanisms, such as the trigger 214 or footpedal 128, may be used by the user to indicate to the computing system102 that the tool axis 207 needs to be maintained to other coordinatesdefined in a surgical plan. For example, the tool axis 207 may bemaintained in a first defined plane, and the user may step on the footpedal 128 to relay to the computing system 102 that the tool axis 207needs to be maintained in a second defined plane.

Surgical Planning and Execution for a Spinal Surgical Application

The surgical plan is created, either pre-operatively orintra-operatively, by a user using planning software. The planningsoftware may be used to a generate three-dimensional (3-D) models of thepatient's bony anatomy from a computed tomography (CT), magneticresonance imaging (MRI), x-ray, ultrasound image data set, or from a setof points collected on the bone intra-operatively. A set of 3-D computeraided design (CAD) models of the manufacturer's pedicle screws may bepre-loaded in the software to further assist the user to define thevirtual pedicle screw plane to designate the best fit, position and/ororientation of the pedicle screw in the pedicle. For example, withreference to FIG. 5, a 3-D model of the patient's spinal column 10 isshown. The final placement of the pedicle screw 24 in the bone model ofthe spinal column 10 defines the pedicle planes 26 where the bone isdrilled intra-operatively to receive the pedicle screw 24 as desired.Surgical device 104′ is a 2-DOF device, which may include an on-boardindicator 28 to indicate when a pin/screw 24 is aligned with the pedicleplane 26.

The surgical plan contains the 3-D model of the patient's operativebones (vertebrae) combined with the location of one or more virtualpedicle planes 26. The location of the pedicle virtual plane(s) 26 maybe defined by the user in the planning software. In a particularembodiment, a user may locate three medial-lateral center points on themodel of the pedicle to define a desired pedicle screw plane 26. Inanother embodiment, the user may virtually place a model of a pediclescrew in a desired POSE on the model of the pedicle. After which, thepedicle screw plane 26 may be defined by a longitudinal center axis ofthe pedicle screw and at least one non-collinear point translated fromthe center axis in the superior-inferior (SI) direction of the pedicle.It should be appreciated, that the final POSE of the model of thepedicle screw in the model of the pedicle provides the other relevantdegrees of freedom such as the desired SI location, SI angle, and depth.In yet another embodiment, the planning system may include tools tooutline a plane in a desired POSE on the pedicle 16. Ultimately, thelocation of the virtual plane(s) 26 is defined to aid in the placementof the pedicle screws 24 in the correct POSE. In another embodiment, ifa robotic system having a robotic arm is used to execute the procedure,the trajectory to insert the pedicle screw with the robotic arm may bedefined in the planning software as the position of a longitudinalcenter axis of the pedicle screw model relative to the bone model. Onlythe center axis is needed to define the trajectory relative to the bone.

In a particular embodiment, the user or the computing system 102 mayactivate the drill tool of the 2-DOF device when properly aligned withthe pedicle plane 26 to drill pilot holes for the pedicle screws 24. Thepedicle screws 24 are then drilled into the pilot holes using a standarddrill. In another embodiment, the user may directly drill the pediclescrew 24 into the pedicle plane 26 without the need for a pilot holewith the drill tool of the 2-DOF device.

There are multiple advantages to using the 2-DOF surgical system 100 toaccurately place the pedicle screws 24. For one, the surgical device 104is actuating in real-time, therefore the user is actively guided to thePOSE of the pedicle plane 26. In addition, the correct position andorientation of the pedicle screws 24 is accurately maintained regardlessof the surgeon's placement of the hand-held portion 204 of the 2-DOFsurgical system 100. Use of a hand-held actuator also avoids thepossibility of inaccuracy in critical directions due to unintendedmechanical deflection of a drill guide when a drill is guided throughthe guide, such as when a robot arm is used to simply hold a drill guidein place. In addition, traditional passive robotic arms and systems areunable to compensate for breathing or cardiac output even with inertiadelayed compensatory mechanisms.

In a specific inventive embodiment, the one or more indicators (223,1906) on a 2-DOF device (104, 104′) or feedback from a monitor 112 maybe used in another inventive method to align the end-effector (e.g.,pedicle screw, bone pin, drill bit) of the 2-DOF on a line (e.g., anaxis, an optimal trajectory for a pedicle screw, a bone tunnel). In theinventive method to align a 2-DOF hand-held surgical device along anaxis, a plane is defined relative to a desired location for an implantor tunnel on a bone, where the implant or tunnel has an axis. Forexample, FIG. 10 depicts a 3-D tibial bone model 300 with a plannedposition of a bone tunnel 302 having an axis 303, and a virtual plane304 defined relative to the bone tunnel 302.

An end-effector of a 2-DOF surgical device is aligned coincident withthe plane, and the 2-DOF surgical device is moved side-to-side while theend-effector maintains coincidence with the plane until a firstindicator signals when the end-effector aligns with an entry point forthe desired location for the implant or tunnel on the bone. FIG. 11depicts an end-effector 206 of the 2-DOF surgical device 104 alignedcoincident with the defined plane 304, where the 2-DoF surgical device104 is moved side-to-side (as indicated by arrow 306) while theend-effector 206 remains coincident with the defined plane 304 by theactuation of the working portion 204.

Subsequently, a tip of the end-effector is anchored into the bone at theentry point; and the 2-DOF surgical device is rotated about the anchoredtip while the end-effector remains coincident with the plane until asecond indicator signals when the end-effector aligns with the axis ofthe implant or tunnel at the desired location. The end effector may thenbe inserted into the bone. FIG. 12 depicts a tip of the end-effector 206anchored in the tibia T at an entry point of the defined location forthe implant or tunnel, where the tip is anchored after an indicator 224signals when the end-effector is aligned with the entry point. FIG. 13depicts the 2-DoF surgical device 104 being rotated (as indicated by thearrow 308) about the anchored tip until the end-effector 206 aligns withthe defined location of the axis 303 of the implant or tunnel. A secondindicator then signals to the user when the end-effector is aligned withthe axis 303.

After the end-effector is aligned with the axis 303, the end-effector isinserted into the bone. If the second indicator is power control, thedrill (e.g., motor 205) automatically turns on when the end-effector 206is aligned with the axis 303 and remains on while inserting theend-effector 206 into the bone. If at any point the end-effector 206veers off-axis from the axis 303 while inserting the end-effector 206 inthe bone, the drill (e.g., motor 205) is automatically turned off.

In specific inventive embodiments, the first indicator and secondindication may be from the same indicator or different indicators.Preferably, the first indicator is an LED on the 2-DOF device thatsignals the entry point by way of a change in color or blinkingfrequency. Alternatively or in combination, the first indicator may bevisual feedback displayed on a monitor. For example, a virtual model ofthe bone may be displayed on the monitor, where the defined plane, axisof the implant or tunnel, and the real-time axis of the end-effector aresuperimposed on the virtual bone model.

The user may then try and align the real-time superimposed axis of theend-effector with the superimposed axis of the implant or tunnel.Additional visual feedback on a monitor may include a simple red andgreen signal, a blinking light that changes frequency based on howclosely it aligns with the entry point. However, keeping the indicatorLED on the device makes it easier for the user to operate as they don'thave to keep looking back and forth between the bone and the monitor. Asfor the second indicator, the same mechanisms may be used as the firstindicator. But, preferably, the second indicator acts as a power controlto the end-effector. For example, once the end-effector aligns with theaxis of the implant or tunnel, the power to the drill is automaticallyturned on to insert the end-effector into the bone. If the user at anypoint veers off-axis from the axis (or the tip moves from the entrypoint), then power to the drill is automatically turned off.

In specific inventive embodiments, the end-effector may include a drillbit, pedicle screw, bone screw, bone pin, a hollow drill bit, burr, bonenail, a reamer, broach, or an implant. The end-effector does notnecessarily have to drive in an implant (e.g., a pedicle screw, THAfemoral stem). For example, the end-effector may be a drill bit thatfirst drills a pilot hole for a pedicle screw, or, the end-effector mayalign a reamer along the central axis of an acetabular cup implant inTHA to prepare the acetabulum.

In specific inventive embodiments, the plane may be defined in severaldifferent ways. Conventional methods may include using pre-operativebone data (CT, MRI, images, 3D bone models) and pre-operative planningsoftware program. The desired placement for the implant or tunnel may bedefined using various tools or widgets in the planning software program(e.g., virtual models of tunnels, virtual models of an implant, a set ofpoints, lines, splines, or planes positionable relative to thepre-operative bone data, a drawing toolbox, etc). Once the position ofthe implant or tunnel is defined, the plane may be defined in severalways. For example, the plane may be defined using at least one of: theaxis of the implant or tunnel and one additional point; or a centralpoint (e.g., entry point) along the axis of the implant or tunnel andtwo additional points. The one or two additional points may be definedby the user on the pre-operative bone in the planning software orautomatically assigned by the planning software. The user may define theone or two additional points on the pre-operative bone data (e.g., bonemodels) based on the expected exposure of the bone during the procedure.The one or two additional points may be anatomical landmarks defined bythe user or the planning software. The planning software may furtherdefine the plane and/or the additional points using historical patientcase data from previous surgeries. The location of the pre-operativelydefined plane may be registered to the bone in the operating room usingregistration techniques known in the art.

Alternatively or in combination in specific inventive embodiments, theplane may be defined on the exposed bone. For example, a user maydigitize three points on the bone with a tracked digitizer or thetracked 2-DOF surgical device to define a plane, or the plane may bedefined using an axis and one additional point. The axis may be definedby aligning the axis of the digitizer or end-effector of the device onthe bone, where the axis of the digitizer or end-effector is recorded bythe computing system to define an axis on the bone. The one additionalpoint is then defined by digitizing a point on the bone with a digitizeror 2-DOF surgical device.

Articulating Screw-Driving Device

The articulating device 204 of the 2-DOF surgical system 100 describedabove can accurately align a tool/pin/screw to be coincident with one ormore virtual planes. However, the surgeon still has to manually advancethe device 204 towards the bone to insert the screw or to create a pilothole for the screw, which may be uncomfortable for the surgeon. In otherwords, the 2-DOF device is only capable of aligning a tool/pin/screw inthe screw plane 26, while the user has to manually control the depth(anterior-posterior direction) of the pin/screw. If an active roboticarm is used however, the robotic arm may control all degrees of freedomto insert a pedicle screw including depth.

To provide further control and feedback for the user with the 2-DOFsurgical device 104, the 2-DOF surgical device 104 may be modified toinclude a third pin/screw-driving degree-of-freedom, which will bereferred to hereinafter as an articulating pin/screw-driver device 104′.With reference to FIGS. 6A-6C in which like reference numerals have themeaning ascribed to that numeral with respect to the aforementionedfigures, a particular embodiment of the articulating pin driver device104′ is shown. In addition to the components of the 2-DOF surgicaldevice 104, the working portion 204′ of the articulating pin driverdevice 104′ further includes components configured to drive a pin 206′into a bone. Specifically, with reference to FIG. 6C, the workingportion 204′ includes the motor 205, a motor coupler 1808, a pin-drivingball screw 1804, a pin holder 1806, and the pin 206′. A speciallyadapted carriage 1810 is configured to support and carry the workingportion 204′ and may include mechanisms for actuating the pin. In someinventive embodiments, the carriage 1810 includes a pin-driving ball nut1812 and connection members 1814 such as holes, bearings, or axlesupports to receive a rod, a dowel, or an axel to act as the hinges (220a, 220 b) that are connected with the first end of the linear rails (208a, 208 b). The motor coupler 1808 couples the motor 205 with thepin-driving ball screw 1804. The pin-driving ball screw 1804 is inmechanical communication with the pin-driving ball nut 1812. The pinholder 1806 connects the pin-driving ball screw 1804 with the pin 206′.The pin 206′ is removably attached with the pin holder 1806 to allow thepin 206′ to remain in the bone when inserted therein. The motor 205 maybi-rotationally drive the pin-driving ball screw 1804 and the pin 206′to advance and drive the pin 206′ into a bone. The components mayfurther include a motor carriage (not shown) operably connected with amotor linear rail (not shown). The motor carriage is secured to themotor 205 to keep the motor 205 from rotating while allowing the motor205 to translate along the motor linear rail. The motor linear rail mayextend from the carriage 1810. FIG. 6A illustrates the pin/screw 206′ ina retracted state and FIG. 6B illustrates the pin/screw 206′ in anextended state, where the pin 206′ can translate a distance “d2”. Anouter guard 1802 may be present to guard the user from the actuatingmechanisms in the working portion 204′. If an outer guard 1802 ispresent, the guard 1802 may be dimensioned to conceal the entire pin206′ when the pin 206′ is in the retracted state, or the guard 1802 mayonly conceal a portion of the pin 206′ to allow the user to visualizethe tip of the pin 206′ prior to bone insertion.

In a specific embodiment, the working portion 204′ may include a firstmotor 205 for rotating the pin 206′, and a second motor (not shown) fortranslationally driving the pin 206′. The second motor may rotate a ballscrew or a worm gear that is in communication with an opposing ball nutor gear rack configured with the first motor 205. As the second motorbi-rotationally drives the ball screw or worm gear, the first motor 205and the pin 206′ translate accordingly.

The device computer 108 of the articulating pin driving device 104′ mayfurther include hardware and software to control the pin-driving action.In an embodiment, the device computer 108 includes two motor controllersfor independently controlling the front actuator 210 a and back actuator210 b, respectively, to maintain the POSE of the working portion (204,204′). A third motor controller may independently control the motor 205for driving and rotating the pin 206′ into the bone. In the specificembodiment where a first motor 205 rotates the pin 206′ and a secondmotor (not shown) translates the pin 206′, the device computer 108 mayinclude two separate motor controllers to independently control thefirst motor 205 and the second motor.

In a specific embodiment, with reference to FIGS. 7A-7B, thearticulating device 104′ includes a bone stabilizing member 1902attached or integrated with the hand-held portion 202. The bonestabilizing member 1902 includes one or more contacting elements (1904a, 1904 b) which are configured to contact the bone and/or skin surfaceto stabilize the hand-held portion 202 while the working portion 204′articulates. The contacting elements (1904 a, 1904 b) may be a flatsurface, a pointed protrusion, or a surface having jagged edges tointeract with the bone and/or soft tissue and stabilize the hand-heldportion 202. The one or more contacting element(s) (1904 a, 1904 b) mayproject just beyond the working portion 204′ such that the element(s)(1904 a, 1904 b) may contact the bone without negatively impacting howdeep the pin/screw 206′ may be inserted in the bone. Alternatively, thecontacting elements (1904 a, 1904 b) may project laterally (i.e.,perpendicular to the pin axis) from the hand-held portion such that thecontacting elements (1904 a, 1904 b) interact with the skin surface ofthe patient. When the user is in the approximate region for driving thepin/screw 206′, the user may stabilize the hand-held portion 202 to thebone and/or soft tissue via the contacting elements (1904 a, 1904 b).With the hand-held portion stabilized, the working portion 204′ furtherarticulates until the pin/screw 206′ is precisely coincident with avirtual pin plane. In a specific embodiment, once the pin/screw 206′aligns with the virtual pin plane 214, the system 100 automaticallylocks the actuators (210 a, 210 b) and activates the motor 205 to drivethe pin/screw 206′ into the bone. In another embodiment, the useractivates a user input mechanism such as a trigger 214 or a buttonbefore the system 100 either locks the actuators (210 a, 210 b), drivesthe pin/screw 206′, or both. Therefore, the user can anticipate andcontrol when the pin/screw 206′ is driven into the bone. This user inputmechanism may similarly be used by the user to control the amount ofextension or retraction of the pin/screw 206′ in general.

In a particular inventive embodiment, with reference to FIG. 7A, one ormore indicators 1906, such as an LED or a display, is attached orintegrated with the device 104′. The indicator 1906 may be attached tothe outer guard 1802, the working portion 204′, or the hand-held portion202 for example. The indicator(s) 1906 provide feedback to the user asto a current position of the device 104′ with respect to a desiredposition for the device 104′. For example, the indicator 1906 may emit ared light to indicate that the device 104′ is outside of the travelranges of the three ball screws (216 a, 216 b, 1804). In other words, ared light is emitted when the working portion 204′ and pin/screw 206′can no longer be articulated to reach a desired position, orientation,or a desired depth to insert the pin/screw 206′. The indicator 1906 mayemit a yellow light when the user is approaching the travel ranges and agreen light when the pin/screw 206′ is aligned with a virtual pin plane.The indicator 1906 may further produce a blinking light that changes inblinking frequency based on how close the device 104′ is to exceedingthe travel range, or how close the pin/screw 206′ is to a virtual pinplane. The indicator 1906 may also indicate when the device 104′ isready to autonomously place the pin inside the bone. In a particularembodiment, the working portion 204′ does not actuate until theindicator 1906 is in an active state, where the active state istriggered when the device 104′ is within the travel limits of the ballscrew. This data conveyed by the indicator 1906 is readily availablebased on either: a) local data collected directly from the device 104′,such as the device kinematics; b) the tracking data collected from thetracking system 106; c) a comparison of the POSE of the device 104′ withthe surgical plan; or d) a combination thereof.

In a specific inventive embodiment, with reference to FIGS. 8A and 8B,the articulating device 104′ includes a partial enclosure 2002. FIG. 8Ais perspective view of the articulating device 104′ with the partialenclosure 2002 and FIG. 8B is a cross-section view thereof. The partialenclosure 2002 is attached to the hand-held portion 202 and partiallyencloses the working portion 204′. The working portion 204′ is able toarticulate within the partial enclosure 2002. The partial enclosure 2002has an internal dimension (i.e. height or diameter) of ‘h’ thatcorresponds to the travel range of the working portion 204′. Thisdimension ‘h’ may account for the translation ‘d’ of the working portion204′ and any additional height required to account for the pitch ‘a’ ofthe working portion 204′. The advantage of the partial enclosure 2002 isto provide the user with a guide as to the workspace or travel range ofthe working portion 204′. The user can simply place a front end of thepartial enclosure 2002 on the bone to stabilize the hand-held portion202, at which time the working portion 204′ can articulate to a virtualpin plane and drive the pin/screw 206′ into the bone. The user is nolonger trying to aim the small pin/screw 206′ directly to a pin/screwplane, but is rather using a larger guide, the partial enclosure 2002,to get the pin/screw 206′ in the general vicinity of a pin/screw planeand allowing the working portion 204′ to perform the alignment. Inaddition, the user no longer has to worry about exceeding the travellimits of the working portion 204′ while aligning the pin/screw 206′.

The front end of the partial enclosure 2002 may act as a bone contactingelement (1904 a, 1904 b) to stabilize the hand-held portion 202 and mayfurther include features such as a jagged edge or one or more pointedprotrusions.

The pin/screw 206′ extends beyond the partial enclosure 2002 in theextended state to allow the pin to be driven into the bone as shown inFIG. 8B. When the pin/screw 206′ is in the retracted state, thepin/screw 206′ is enclosed within the partial enclosure 2002.

The partial enclosure 2002 may further include the indicator 1906 to aidthe user in positioning the device 104′ to a desired pin plane asdescribed above.

The partial enclosure 2002 is further configured to allow the trackingarray 212 to attach with the working portion 204′, or an outer guard1802′ of the working portion 204′, to permit the tracking system 106 totrack the POSE of the working portion 204′ as it articulates.

In a particular inventive embodiment, with reference to FIGS. 9A and 9B,the articulating device 104′ includes a full enclosure 2102. FIG. 9A isa perspective view of the articulating device 102 with the fullenclosure 2102 and FIG. 9B is a cross-section view thereof. The fullenclosure 2102 is configured with the same principles and has the sameadvantages as the partial enclosure 2002, except the tracking array 212is attached directly to the full enclosure 2102. Since the trackingarray 212 is attached to the full enclosure 2102, the control scheme forcontrolling the working portion 204′ must be modified, where the devicekinematics are used to determine the POSE of the working portion 204′.Particularly, the tracking system 106 tracks the hand-held portion 202based on the geometric relationship between the array 212 and thehand-held portion 202, and the actuator (210 a, 210 b) positions (i.e.the rotational position of the actuators that corresponds to theposition of the ball nuts (218 a, 218 b) on the ball screws (216 a, 216b)) are used to determine the POSE of the working portion 204′ withrespect to the hand-held portion 202. Therefore, the computing system102 can determine new actuator positions to control and align thepin/screw 206′ with a virtual pin plane.

It should be appreciated that the partial enclosure 2002 and fullenclosure 2102 may be sized and adapted for assembly to a hand-heldsystem having greater than two degrees of freedom with similaradvantages. For example, it is contemplated that the inner dimensions ofthe enclosure (226, 228) may accommodate the travel limits of a devicehaving an articulating portion that articulates in one or moretranslational directions, pitch, and yaw such as the system described inU.S. Patent Publication No. 2013/0060278. However, as the number ofdegrees of freedom increase, so does the size of the enclosure (226,228) which may impede the operating workspace.

It should be further appreciated that the embodiments of the bonestabilizing member 1902, the indicator 1906, the partial enclosure 2002,and full enclosure 2102, can all be adapted for use with the 2-DOFsurgical device 104 as shown in FIGS. 4A-4B.

Bi-Cortical Drilling

To further stabilize the pedicle screws in the bone it may be desirableto drill the pins through two cortical regions of the bone, alsoreferred to as bi-cortical drilling. However, if a drill bit or apedicle screw is drilled beyond the second cortical region and into thesoft tissue, patient harm can occur. Therefore, it is proposed that thethird pin-driving actuation axis can also be used to retract the drillbit/pin if the drill bit/screw breaks through the second corticalregion.

In a particular inventive embodiment, bone breakthrough is detectedusing an existing method, such as the method described in Taha, Zahari,A. Salah, and J. Lee. “Bone breakthrough detection for orthopedicrobot-assisted surgery.” APIEMS 2008 Proceedings of the 9th Asia PacificIndustrial Engineering and Management Systems Conference. 2008. Thearticulating pin-driving device 104′ then automatically retracts thedrill bit/pin at a constant optimal retraction speed relative to thebone, regardless of how the user is moving the hand-held portion 202.This ensures that if the drill bit/pin breakthrough the second corticalregion, that the drill bit/pin is retracted so as to not cause anypatient harm. The retraction speed is a function of the optimalretraction speed combined with the current speed of the hand-heldportion 202.

The relative speed between the hand-held portion 202 and the bone can bemeasured several different ways. In one embodiment, the speed of thehand-held portion 202 relative to the bone is not detected and instead aspeed is assumed. In another embodiment, a simple linear distancemeasuring tool is used, such as a laser distance measurement device. Ina particular embodiment, the tracking system 106 is used to track boththe bone and the hand-held portion 202 using one or more fiducialmarkers on each of the bone and the hand-held portion 202.

OTHER EMBODIMENTS

While at least one exemplary embodiment has been presented in theforegoing detailed description, it should be appreciated that a vastnumber of variations exist. It should also be appreciated that theexemplary embodiment or exemplary embodiments are only examples, and arenot intended to limit the scope, applicability, or configuration of thedescribed embodiments in any way. Rather, the foregoing detaileddescription will provide those skilled in the art with a convenientroadmap for implementing the exemplary embodiment or exemplaryembodiments. It should be understood that various changes can be made inthe function and arrangements of elements without departing from thescope as set forth in the appended claims and the legal equivalentsthereof.

Patents, patent application publications, and other literaturereferences cited herein are indicative of the level of the skill in theart. Each patents, patent application publication, and other literaturereference is hereby incorporated by reference, each in its entirety.These references are intended to be incorporated to the same extent asis each reference was individual incorporated by reference.

The foregoing description is illustrative of particular embodiments ofthe invention, but is not meant to be a limitation upon the practicethereof. The following claims, including all equivalents thereof, areintended to define the scope of the invention.

1. A method to align a 2-DOF hand-held surgical device along an axis,comprising: defining a plane relative to a desired location for animplant or tunnel on a bone, said implant or tunnel having an axis;aligning an end-effector of the 2-DOF surgical device coincident withthe plane; and moving the 2-DOF surgical device about the bone while theend-effector maintains coincidence with the plane until a firstindicator signals when the end-effector aligns with at least one of: anentry point for the desired location for the implant or tunnel on thebone; or the axis of the implant or tunnel at the desired location. 2.The method of claim 1 further comprising: moving the 2-DOF surgicaldevice side-to-side while the end-effector maintains coincidence withthe plane until the first indicator signals when the end-effector alignswith the entry point for the desired location for the implant or tunnelon the bone; anchoring a tip of the end-effector into the bone at theentry point; and rotating the 2-DOF surgical device about the anchoredtip while the end-effector remains coincident with the plane until asecond indicator signals when the end-effector aligns with the axis ofthe implant or tunnel at the desired location.
 3. The method of claim 1further comprising inserting the end-effector into the bone.
 4. Themethod of claim 2 wherein the first indicator and the second indicatorare the same indicator.
 5. The method of claim 1 wherein the firstindicator is at least one of: a red and a green signal; and a blinkinglight that changes frequency based on how closely the end-effectoraligns with the entry point or axis of the implant or tunnel at thedesired location.
 6. The method of claim 2 wherein the second indicatoris at least one of: a red and a green signal; and a blinking light thatchanges frequency based on how closely the end-effector aligns with theaxis of the implant or tunnel at the desired location.
 7. The method ofclaim 1 wherein the first indicator is displayed using a monitor, or anon-board indicator of the 2-DOF surgical tool that provides feedback tothe user.
 8. The method of claim 7 wherein the on-board indicatorcomprises one or more light emitting diode (LED) for direct visualfeedback when the 2-DOF surgical tool is aligned with at least one ofthe entry point or the axis of the implant or tunnel.
 9. The method ofclaim 8 further comprising displaying a virtual model of the bone is onthe monitor, where the defined plane, axis of the implant or tunnel, anda real-time axis of the end-effector are superimposed on the virtualbone model.
 10. The method of claim 10 further comprising aligning thesuperimposed real-time axis of the end-effector with the superimposedaxis of the implant or tunnel.
 11. The method of claim 8 wherein themonitor further provides visual feedback as at least one of: a red and agreen signal; and a blinking light that changes frequency based on howclosely the end-effectors aligns with the entry point.
 12. The method ofclaim 2 wherein the second indicator is a power control to theend-effector wherein when the end-effector aligns with the axis of theimplant or tunnel, the power to a drill of the end-effector isautomatically turned on to insert the end-effector into the bone; andwherein if the end-effector veers off-axis from the axis, or the tipmoves from the entry point, then power to the drill is automaticallyturned off.
 13. The method of claim 1 wherein the end-effector comprisesone of a dill bit, pedicle screw, bone screw, bone pin, a hollow drillbit, burr, bone nail, a reamer, broach, or an implant.
 14. The method ofclaim 1 wherein the plane is defined using pre-operative bone data (CT,MRI, images, 3D bone models) and a pre-operative planning softwareprogram.
 15. The method of claim 1 wherein the desired placement for theimplant or tunnel is defined using tools or widgets in a planningsoftware program, the tool and widgets comprising at least one ofvirtual models of tunnels, virtual models of an implant, a set ofpoints, lines, splines, or planes positionable relative to a set ofpre-operative bone data, and a drawing toolbox.
 16. A system forimplementing the method claim 1 wherein said system comprises: acomputing system; an articulating 2-DOF surgical device; and a trackingsystem.
 17. The system of claim 16 wherein the articulating 2-DOFsurgical device comprises: a working portion configured to articulate; ahand-held portion pivotably connected to the working portion by a frontlinear rail and a rear linear rail, said front linear rail and said rearlinear rail actuated by a set of components in the hand-held portion toadjust pitch and translation of the working portion relative to thehand-held portion, said front linear rail and said rear linear rail eachhaving a first end and a second end; and a tracking array having a setof three or more fiducial markers rigidly attached to the workingportion to permit a tracking system to track a position and orientation(POSE) of the working portion.
 18. The system of claim 17 furthercomprising: a front actuator that powers a front ball screw, and a backactuator that powers a back ball screw, where the first end of both saidfront linear rail and said rear linear rail are each attached to saidworking portion via a set of hinges allowing said working portion topivot relative to said front linear rail and said rear linear rail; anda set of ball nuts integrally attached at a second end of both saidfront linear rail and said rear linear rail, said set of ball nuts inmechanical communication with both said front ball screw and said backball screw; said set of ball nuts translate along the axis of the ballscrews to adjust the pitch and translation of said working portion. 19.The system of claim 16 wherein the articulating 2-DOF surgical devicefurther comprises an on-board indicator configured to provide feedbackto a user based on an actual position of said working portion relativeto a desired position for said working portion.